Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

NCT03115424 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 16-004253
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.

Conditions

Obesity

Keywords

Weight Loss; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Weight

  Subjects calculated weight in kilograms

  baseline and 36 months

Secondary Outcomes (3)

• Systolic Blood Pressure

  baseline and 36 months

• Diastolic Blood Pressure

  baseline and 36 months

• Low-density Lipoprotein (LDL)

  baseline and 36 months

Study Arms (3)

Sleeve Gastrectomy Placebo

PLACEBO COMPARATOR

Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.

Drug: Placebos

Sleeve Gastrectomy Saxenda

ACTIVE COMPARATOR

Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.

Drug: Saxenda

RYGB

SHAM COMPARATOR

Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.

Procedure: RYGB

Interventions

Saxenda DRUG

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects will be recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will be randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Also known as: Liraglutide

Sleeve Gastrectomy Saxenda

Placebos DRUG

Subjects will be recruited and screened prior to undergoing bariatric surgery.Subjects undergoing SG will be randomized 1:1 at months 3 post surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Also known as: Placebo for Saxenda (Liraglutide)

Sleeve Gastrectomy Placebo

RYGB PROCEDURE

Subjects will be recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

RYGB

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-65 years of age
• Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.
• No active physical illness which will interfere with mobility or weight loss after bariatric surgery.
• Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

You may not qualify if:

• Prior use of glucose lowering medication in the 3 months prior to screening.
• A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.
• Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
• Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
• Hypersensitivity to liraglutide or any product components.
• Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.
• Prior history of pancreatitis, cholelithiasis or cholecystitis.
• Concurrent use of insulin or any other GLP-1 receptor agonist.
• Active, severe psychiatric disease

Sponsors & Collaborators

• Mayo Clinic: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Adrian Vella, M.D.
• Organization: Mayo Clinic

vella.adrian@mayo.edu

507-266-1387

Study Officials

• Adrian Vella

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind design.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: June 22, 2017
• Primary Completion: October 4, 2023
• Study Completion: May 30, 2024
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)